-
3
-
-
0043005476
-
Bioequivalence trials, intersection-union tests, and equivalence confidence sets
-
Berger R., Hsu J. Bioequivalence trials, intersection-union tests, and equivalence confidence sets. Statistical Sci. 11:1996;283-319.
-
(1996)
Statistical Sci.
, vol.11
, pp. 283-319
-
-
Berger, R.1
Hsu, J.2
-
5
-
-
0043003669
-
Biostatistical methodology in clinical trials in applications for marketing authorization for medical products
-
EC-GCP, Brussels
-
EC-GCP, 1993. Biostatistical methodology in clinical trials in applications for marketing authorization for medical products. CPMP Working Party on Efficiency of Medical Products, Draft Guideline Edition, Brussels.
-
(1993)
CPMP Working Party on Efficiency of Medical Products, Draft Guideline Edition
-
-
-
6
-
-
0008990452
-
-
FDA, Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD
-
FDA, 1992. FDA guidance on statistical procedures for bioequivalence studies using a standard two-treatment crossover design. Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD.
-
(1992)
FDa Guidance on Statistical Procedures for Bioequivalence Studies Using a Standard Two-treatment Crossover Design
-
-
-
7
-
-
0003556721
-
-
FDA, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), August 1999, BP
-
FDA, 1999. Draft guidance on Average, Population, and Individual Approaches to Establishing Bioequivalence U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), August 1999, BP.
-
(1999)
Draft Guidance on Average, Population, and Individual Approaches to Establishing Bioequivalence
-
-
-
8
-
-
0000590222
-
The validity of the test of individual equivalence ratios (TIER)
-
Hwang J.T., Wang W. The validity of the test of individual equivalence ratios (TIER). Biometrika. 84(4):1997;893-900.
-
(1997)
Biometrika
, vol.84
, Issue.4
, pp. 893-900
-
-
Hwang, J.T.1
Wang, W.2
-
9
-
-
0030982951
-
A two one-sided tests procedure for assessment of individual bioequivalence
-
Liu J.P., Chow S.C. A two one-sided tests procedure for assessment of individual bioequivalence. J. Biopharmaceutical Statist. 7:1997;49-61.
-
(1997)
J. Biopharmaceutical Statist.
, vol.7
, pp. 49-61
-
-
Liu, J.P.1
Chow, S.C.2
-
10
-
-
84950182824
-
On Assessment of Bioequivalence in Variability of Bioavailability Studies
-
Liu J.P., Chow S.C. On Assessment of Bioequivalence in Variability of Bioavailability Studies. Commun. Statist. Part A. 21:1992;2591-2607.
-
(1992)
Commun. Statist. Part a
, vol.21
, pp. 2591-2607
-
-
Liu, J.P.1
Chow, S.C.2
-
11
-
-
0027668869
-
A log-normal model for individual bioequivalence
-
Phillips K.F. A log-normal model for individual bioequivalence. J. Biopharmaceutical Statist. 3:1993;185-201.
-
(1993)
J. Biopharmaceutical Statist.
, vol.3
, pp. 185-201
-
-
Phillips, K.F.1
-
12
-
-
0029083127
-
Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar
-
Schall R. Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar. Biometrics. 51:1995;615-626.
-
(1995)
Biometrics
, vol.51
, pp. 615-626
-
-
Schall, R.1
-
13
-
-
0027244039
-
On population and individual bioequivalence
-
Schall R., Luus H.G. On population and individual bioequivalence. Statist. Med. 12:1993;1109-1124.
-
(1993)
Statist. Med.
, vol.12
, pp. 1109-1124
-
-
Schall, R.1
Luus, H.G.2
-
14
-
-
0030011261
-
Towards a practical strategy for assessing individual bioequivalence
-
(for FDA individual bioequivalence working group)
-
Schall, R., Williams, R.L., 1996. Towards a practical strategy for assessing individual bioequivalence. J. Pharmacokinetics Biopharmaceutics 24(1) 133-149 (for FDA individual bioequivalence working group).
-
(1996)
J. Pharmacokinetics Biopharmaceutics
, vol.24
, Issue.1
, pp. 133-149
-
-
Schall, R.1
Williams, R.L.2
-
15
-
-
0026481178
-
Bioequivalence revisited
-
Sheiner L.B. Bioequivalence revisited. Statist. Med. 11:1992;1777-1788.
-
(1992)
Statist. Med.
, vol.11
, pp. 1777-1788
-
-
Sheiner, L.B.1
-
17
-
-
21744458372
-
Optimal unbiased tests for equivalence in intra-subject variability
-
Wang W. Optimal unbiased tests for equivalence in intra-subject variability. J. Amer. Statist. Assoc. 92:1997;1163-1170.
-
(1997)
J. Amer. Statist. Assoc.
, vol.92
, pp. 1163-1170
-
-
Wang, W.1
-
18
-
-
1542742686
-
On testing of individual bioequivalence
-
Wang W. On testing of individual bioequivalence. J. Amer. Statist. Assoc. 94:1999;880-887.
-
(1999)
J. Amer. Statist. Assoc.
, vol.94
, pp. 880-887
-
-
Wang, W.1
-
19
-
-
0040248082
-
Vorschläge zur Reformulierung der statistischen Definition von Bioäquivalenz
-
Springer, Berlin, Heidelberg
-
Wellek, S., 1989. Vorschläge zur Reformulierung der statistischen Definition von Bioäquivalenz, Medizinische Informatik und Statistik, Vol. 71, Springer, Berlin, Heidelberg, pp. 95-99.
-
(1989)
Medizinische Informatik und Statistik
, vol.71
, pp. 95-99
-
-
Wellek, S.1
-
20
-
-
84985644178
-
Basing the analysis of comparative bioavailability trials on an individualized statistical definition of equivalence
-
Wellek S. Basing the analysis of comparative bioavailability trials on an individualized statistical definition of equivalence. Biometrical J. 35(1):1993;47-55.
-
(1993)
Biometrical J.
, vol.35
, Issue.1
, pp. 47-55
-
-
Wellek, S.1
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